Analgesic Effect of Liposomal Bupivacaine

NCT05118399 | Completed Phase 4

• 1 other identifier: UW21-046
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Brachial plexus blocks (BPB) are commonly used to provide regional anaesthesia for patients undergoing distal radial fracture surgery. Distal radial (DR) fracture surgery is a commonly performed orthopaedic surgery, and is usually associated with moderate postoperative pain. Poor postoperative pain control can impair rehabilitation, delay recovery and negatively impact outcomes after surgery. Liposomal bupivacaine (EXPAREL) is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine. Liposomal bupivacaine can provide longer analgesia for up to 72 hours, and may therefore achieve greater analgesic efficacy compared to non-liposomal long-acting local anaesthetics. A number of clinical trials have studied the effect liposomal bupivacaine given as local infiltration. However, there is little evidence on liposomal bupivacaine for regional nerve blocks, and the use of liposomal bupivacaine for supraclavicular brachial plexus block - which is used for regional anaesthesia for distal radial fracture surgery - have not been studied before. This project is a randomized controlled trial to determine whether adding liposomal bupivacaine to long-acting local anaesthetics for supraclavicular BPB will improve and prolong postoperative analgesia in patients undergoing distal radial fracture surgery. Longer term secondary outcomes would be accessed including upper limb functional scores, chronic pain, and health related quality of life.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• postoperative AUC pain score at rest

  Pain severity would be rated at rest after surgery using numerical rating scale with 0 to 10 where 0=no pain and 10=the worst possible pain

  First 48 hours after surgery

Study Arms (2)

To receive supraclavicular BPB using standard ropivacaine only.

ACTIVE COMPARATOR

20ml of plain bupivacaine will be injected using 2 syringes, so 10ml of 0.5% plain bupivacaine will be injected, and immediately followed by another 10ml of 0.5% plain bupivacaine.

Drug: Bupivacaine Injection [Marcaine]

To receive supraclavicular BPB using liposomal bupivacaine together with ropivacaine.

EXPERIMENTAL

10ml of 0.5% plain bupivacaine will be injected, and immediately followed by 10ml of 1.33% liposomal bupivacaine.

Drug: Bupivacaine Liposome 13.3 MG/ML [Exparel]

Interventions

Bupivacaine Injection [Marcaine] DRUG

Bupivacaine injection \[Marcaine\] is the standard treatment used in our hospital.

To receive supraclavicular BPB using standard ropivacaine only.

Bupivacaine Liposome 13.3 MG/ML [Exparel] DRUG

Bupivacaine liposome is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine.

To receive supraclavicular BPB using liposomal bupivacaine together with ropivacaine.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist (ASA) status I-III
• Age 18-90 years old
• Scheduled for distal radial fracture fixation (Open reduction and internal fixation with volar approaching locking plate)
• Patients with informed consent to participate in the study

You may not qualify if:

• Ulnar shaft/ neck physis fracture
• Revision surgery
• Previous fractures or surgery in the affected distal radius
• Surgery involving more than the affected arm
• Higher energy and high-grade fracture cases - road traffic accident, fall from height, open fractures, combined distal radius and distal ulna fractures, fractures requiring external fixation, fractures with severe articular comminution or severe metaphyseal extension, comminuted fractures requiring more than a single volar approach incision and a single volar locking plate implant
• Cases with painful conditions affecting the upper limb prior to surgery such as cervical spine, shoulder, elbow, other hand and wrist problems
• Cases with baseline (pre-injury) QuickDASH score worse than 10 out of 100
• Respiratory compromise (requires long term oxygen)
• History of seizures
• Pre-existing neurological disorder/deficit
• Chronic opioid user (use for 3 months or more)
• Presence of chronic pain condition (pain duration over 3 months)
• Alcohol or substance abuse
• Psychiatric illness
• Impaired mental state

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 12, 2021
• Study Start: November 15, 2021
• Primary Completion: December 8, 2022
• Study Completion: March 8, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

HK (1)